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Feds Warn SSRI-Caused
Worsening Depression,
Suicide Thoughts
FDA Urges Caution Over
Antidepressant Use

3-22-4



WASHINGTON (Reuters) - Patients taking anti-depressants, including children and teenagers, should be closely monitored for signs of worsening depression and suicidal thoughts, U.S. health authorities said on Monday.
 
The warning comes after a panel of experts last month called on the U.S. Food and Drug Administration to issue stronger warnings about the possible risks of suicidal behavior among children and teenagers taking antidepressant drugs.
 
U.S. health officials are studying whether antidepressants can make children and teenagers suicide-prone but have not yet reached a conclusion.
 
"It is not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behavior," the FDA said in a statement.
 
Questions about a possible link with suicidal behavior arose last year when regulators were reviewing clinical trials of children who took GlaxoSmithKline Plc's Paxil.
 
The other antidepressants the FDA is evaluating include Forest Laboratories Inc.'s Celexa, Solvay's Luvox, Akzo Nobel's Remeron, Bristol-Myers Squibb's Serzone, Pfizer's Zoloft, Eli Lilly and Co.'s Prozac, and Wyeth's Effexor.
 
Only Prozac, sold generically as fluoxetine, is approved for treating pediatric depression.
 
The FDA advised patients and doctors watch for signs of hostility, anxiety, insomnia and other behaviors that could signal worsening depression and suicidal thoughts.
 
The agency asked manufacturers to change the labels of 10 drugs to include stronger warnings about patient monitoring.
 
Copyright © 2004 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.



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